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Oncology Late-Stage Clinical Research Scientist
2 months ago
Pfizer is seeking a highly experienced and skilled Clinical Research Director to lead our Late-Stage Oncology portfolio. As a key member of our team, you will be responsible for providing scientific oversight and ensuring the quality of clinical trials.
Key Responsibilities- Provide scientific expertise and guidance to clinical trial teams to ensure the successful implementation and execution of clinical trials.
- Develop and maintain current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
- Collaborate with cross-functional teams, including clinical operations, safety, and regulatory, to ensure the quality and integrity of clinical trials.
- Represent the study team in governance meetings and submissions, and partner with the Development lead/Medical Director to develop and implement study and disease area strategies.
- Author and review clinical and regulatory documents, including protocols, informed consent documents, and clinical study reports.
- Lead the collection and review of clinical data, and present findings to internal and external stakeholders.
- Partner with medically qualified colleagues to analyze emerging safety profiles and inform clinical and safety colleagues of changes in the safety profile.
- Ensure compliance with relevant SOPs and regulations, and participate in portfolio- and enterprise-level workgroups to optimize clinical development procedures.
- Science degree (PhD, PharmD, or equivalent) and minimum of 7-year Clinical Research experience in industry/CRO, OR BA/BS and minimum of 10-year Clinical Research experience in a similar role in industry/CRO.
- Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval.
- Excellent knowledge of clinical procedures, ICH guidelines, GCP, and familiarity with FDA, EMA, and global regulations.
- Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English.
- Proven analytical skills with the ability to work on large data sets.
- Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
- Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development.
- Relocation assistance may be available based on business needs and/or eligibility.
